Eric Pelfrene - Academia.edu (original) (raw)

Papers by Eric Pelfrene

Journal of Global Health, Jun 1, 2016

SV is a major cause of morbidity and mortality worldwide. Although no treatment or vaccine curren... more SV is a major cause of morbidity and mortality worldwide. Although no treatment or vaccine currently exists, RSV therapeutics and preventative strategies are being evaluated in clinical trials, including phase 3 trials. Despite great prospects, the regulatory pathways of novel RSV therapeutics have been defined insufficiently. Here we report the results from the ReSViNET 2nd High-level expert meeting 2016 on RSV therapeutics, which was held in Zeist, the Meeting`Report:`Harmonization`ofR SV`therapeutics`-`from`design`top erformance

International Journal of Tuberculosis and Lung Disease, Dec 1, 2015

International Health, Apr 8, 2015

Malaria remains a major public health challenge with almost half of the world's population expose... more Malaria remains a major public health challenge with almost half of the world's population exposed to the risk of contracting the illness. Prompt, effective and well tolerated treatment remains one of the cornerstones in the disease management, with artemisinin-based combination therapy the recommended option for non-severe malaria in endemic areas with predominant Plasmodium falciparum infections. Recent experience has been obtained at the European Medicines Agency with regulatory approval of two such antimalarial fixed combination products. For these cases, two different regulatory pathways were applied. As such, the present contribution describes this experience, emphasising main differences and applicability offered by these regulatory choices.

Clinical Infectious Diseases, Jul 31, 2016

Background. The etiology of hospital-acquired or ventilator-associated bacterial pneumonia (HABP/... more Background. The etiology of hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP) is often multidrugresistant infections. The evaluation of new antibacterial drugs for efficacy in this population is important, as many antibacterial drugs have demonstrated limitations when studied in this population. HABP/VABP trials are expensive and challenging to conduct due to protocol complexity and low patient enrollment, among other factors. The Clinical Trials Transformation Initiative (CTTI) seeks to advance antibacterial drug development by streamlining HABP/VABP clinical trials to improve efficiency and feasibility while maintaining ethical rigor, patient safety, information value, and scientific validity. Methods. In 2013, CTTI engaged a multidisciplinary group of experts to discuss challenges impeding the conduct of HABP/ VABP trials. Separate workstreams identified challenges associated with HABP/VABP protocol complexity. The Project Team developed potential solutions to streamline HABP/VABP trials using a Quality by Design approach. Results. CTTI recommendations focus on 4 key areas to improve HABP/VABP trials: informed consent processes/practices, protocol design, choice of an institutional review board (IRB), and trial outcomes. Informed consent processes should include legally authorized representatives. Protocol design decisions should focus on eligibility criteria, prestudy antibacterial therapy considerations, use of new diagnostics, and sample size. CTTI recommends that sponsors use a central IRB and discuss trial endpoints with regulators, including defining a clinical failure and evaluating the impact of concomitant antibacterial drugs. Conclusions. Streamlining HABP/VABP trials by addressing key protocol elements can improve trial startup and patient recruitment/retention, reduce trial complexity and costs, and ensure patient safety while advancing antibacterial drug development. Keywords. hospital-acquired bacterial pneumonia; ventilator-associated bacterial pneumonia; protocol development; clinical trials; CTTI.

Journal of Antimicrobial Chemotherapy, Apr 10, 2016

Despite the recognized problem of antibiotic multidrug resistance, very few antibacterial agents ... more Despite the recognized problem of antibiotic multidrug resistance, very few antibacterial agents with new mechanisms of action are under development. Bacteriophage therapy could offer one alternative strategy to mitigate this challenge. Although widely used throughout the 20th century in Eastern Europe and the former Soviet Union, this potential therapy has not yet been investigated according to rigorous scientific standards. This paper reports on a multistakeholder meeting held at the EMA, which outlined the existing regulatory framework to which such therapy should adhere and reviewed the current obstacles and shortcomings in scientific development for bacteriophage therapy.

Antimicrobial Resistance and Infection Control, Jan 29, 2021

Background: Antimicrobial resistance (AMR) is a growing global problem to which the ongoing COVID... more Background: Antimicrobial resistance (AMR) is a growing global problem to which the ongoing COVID-19 pandemic may further contribute. With resources deployed away from antimicrobial stewardship, evidence of substantial preemptive antibiotic use in COVID-19 patients and indirectly, with deteriorating economic conditions fuelling poverty potentially impacting on levels of resistance, AMR threat remains significant. Main body: In this paper, main AMR countermeasures are revisited and priorities to tackle the issue are reiterated. The need for collaboration is stressed, acknowledging the relationship between human health, animal health and environment ("One Health" approach). Among the stated priorities, the initiative by the European Medicines Regulatory Network to further strengthen the measures in combatting AMR is highlighted. Likewise, it is asserted that other emerging health threats require global collaboration with the One Health approach offering a valuable blueprint for action. Conclusion: The authors stress the importance of an integrated preparedness strategy to tackle this public health peril.

Clinical Infectious Diseases, Jul 31, 2016

Background. Resistant bacteria are one of the leading causes of hospital-acquired/ventilator-asso... more Background. Resistant bacteria are one of the leading causes of hospital-acquired/ventilator-associated bacterial pneumonia (HABP/VABP). HABP/VABP trials are complex and difficult to conduct due to the large number of medical procedures, adverse events, and concomitant medications involved. Differences in the legislative frameworks between different regions of the world may also lead to excessive data collection. The Clinical Trials Transformation Initiative (CTTI) seeks to advance antibacterial drug development (ABDD) by streamlining clinical trials to improve efficiency and feasibility while maintaining ethical rigor, patient safety, information value, and scientific validity. Methods. In 2013, CTTI engaged a multidisciplinary group of experts to discuss challenges impeding the conduct of HABP/ VABP trials. Separate workstreams identified challenges associated with current data collection processes. Experts defined "data collection" as the act of capturing and reporting certain data on the case report form as opposed to recording of data as part of routine clinical care. The ABDD Project Team developed strategies for streamlining safety data collection in HABP/VABP trials using a Quality by Design approach. Results. Current safety data collection processes in HABP/VABP trials often include extraneous information. More targeted strategies for safety data collection in HABP/VABP trials will rely on optimal protocol design and prespecification of which safety data are essential to satisfy regulatory reporting requirements. Conclusions. A consensus and a cultural change in clinical trial design and conduct, which involve recognition of the need for more efficient data collection, are urgently needed to advance ABDD and to improve HABP/VABP trials in particular. Keywords. hospital-acquired bacterial pneumonia; ventilator-associated bacterial pneumonia; data collection; clinical trials; CTTI.

Clinical Microbiology and Infection, 2019

Background: The paucity of licensed monoclonal antibodies (mAbs) in the infectious diseases arena... more Background: The paucity of licensed monoclonal antibodies (mAbs) in the infectious diseases arena strongly contrasts with the ready availability of these therapeutics for use in other conditions. Aims: This narrative review aims to assess the potential of monoclonal antibody-based interventions for infectious diseases. Sources: A review of the literature via the Medline database was performed and complemented by published official documents on licensed anti-infective mAbs. In addition, ongoing trials were identified through a search of the clinical trial registration platform ClinicalTrials.gov. Content: We identified the few infections for which mAbs have been added to the therapeutic armamentarium and stressed their potential in representing a readily available protection tool against biothreats and newly emerging and reemerging infectious agents. In reviewing the historical context and main features of mAbs, we assert a potentially wider applicability and cite relevant examples of ongoing therapeutic developments. Factors hindering successful introduction of mAbs on a larger scale are outlined and thoughts are offered on how to possibly address some of these limitations. Implications: mAbs may represent important tools in treating or preventing infections occurring with reasonably sufficient prevalence to justify demand and for which existing alternatives are not deemed fully adequate. Future initiatives need to address the prohibitive costs encountered in the development process. The feasibility of more large-scale administration of alternative modalities merits further exploration. In order to ensure optimal prospect of regulatory success, an early dialogue with competent authorities is encouraged.

The Lancet Infectious Diseases, 2015

Sepsis is a common and lethal syndrome: although outcomes have improved, mortality remains high. ... more Sepsis is a common and lethal syndrome: although outcomes have improved, mortality remains high. No specifi c anti-sepsis treatments exist; as such, management of patients relies mainly on early recognition allowing correct therapeutic measures to be started rapidly, including administration of appropriate antibiotics, source control measures when necessary, and resuscitation with intravenous fl uids and vasoactive drugs when needed. Although substantial developments have been made in the understanding of the basic pathogenesis of sepsis and the complex interplay of host, pathogen, and environment that aff ect the incidence and course of the disease, sepsis has stubbornly resisted all eff orts to successfully develop and then deploy new and improved treatments. Existing models of clinical research seem increasingly unlikely to produce new therapies that will result in a step change in clinical outcomes. In this Commission, we set out our understanding of the clinical epidemiology and management of sepsis and then ask how the present approaches might be challenged to develop a new roadmap for future research.

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2016

BACKGROUND Resistant bacteria are one of the leading causes of hospital-acquired/ventilator-assoc... more BACKGROUND Resistant bacteria are one of the leading causes of hospital-acquired/ventilator-associated bacterial pneumonia (HABP/VABP). HABP/VABP trials are complex and difficult to conduct due to the large number of medical procedures, adverse events, and concomitant medications involved. Differences in the legislative frameworks between different regions of the world may also lead to excessive data collection. The Clinical Trials Transformation Initiative (CTTI) seeks to advance antibacterial drug development (ABDD) by streamlining clinical trials to improve efficiency and feasibility while maintaining ethical rigor, patient safety, information value, and scientific validity. METHODS In 2013, CTTI engaged a multidisciplinary group of experts to discuss challenges impeding the conduct of HABP/VABP trials. Separate workstreams identified challenges associated with current data collection processes. Experts defined "data collection" as the act of capturing and reporting cer...

Phage Therapy: A Practical Approach, 2019

With the recognition of the threat posed by bacterial multi-drug resistance, the bacteriophage tr... more With the recognition of the threat posed by bacterial multi-drug resistance, the bacteriophage treatment concept has been revived as an alternative in the armamentarium. Over the last decade, research efforts on bacteriophage therapy have intensified, and stakeholders have called upon regulatory authorities in trying to define a bespoke licensing pathway for bacteriophages which would not adversely affect the standards required for quality, safety and efficacy. In this context, and in particular concerning the use of personalised phage cocktails, the concept of “hybrid licensing”, with patient-specific phage therapy selected from a local pre-authorised phage library, has recently been advanced. To date, however, and notwithstanding encouraging data, important knowledge gaps remain regarding the safe and effective administration of bacteriophages. Therefore, generation of further scientifically robust data concerning proposed bacteriophage therapies as well as extensive stakeholder c...

Antimicrobial Resistance and Infection Control, 2021

Background Antimicrobial resistance (AMR) is a growing global problem to which the ongoing COVID-... more Background Antimicrobial resistance (AMR) is a growing global problem to which the ongoing COVID-19 pandemic may further contribute. With resources deployed away from antimicrobial stewardship, evidence of substantial pre-emptive antibiotic use in COVID-19 patients and indirectly, with deteriorating economic conditions fuelling poverty potentially impacting on levels of resistance, AMR threat remains significant. Main body In this paper, main AMR countermeasures are revisited and priorities to tackle the issue are re-iterated. The need for collaboration is stressed, acknowledging the relationship between human health, animal health and environment (“One Health” approach). Among the stated priorities, the initiative by the European Medicines Regulatory Network to further strengthen the measures in combatting AMR is highlighted. Likewise, it is asserted that other emerging health threats require global collaboration with the One Health approach offering a valuable blueprint for action...

International Health, 2015

Malaria remains a major public health challenge with almost half of the world's population ex... more Malaria remains a major public health challenge with almost half of the world's population exposed to the risk of contracting the illness. Prompt, effective and well tolerated treatment remains one of the cornerstones in the disease management, with artemisinin-based combination therapy the recommended option for non-severe malaria in endemic areas with predominant Plasmodium falciparum infections. Recent experience has been obtained at the European Medicines Agency with regulatory approval of two such antimalarial fixed combination products. For these cases, two different regulatory pathways were applied. As such, the present contribution describes this experience, emphasising main differences and applicability offered by these regulatory choices.